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Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

Primary Purpose

Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PEEP (positive end-expiratory pressure)
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery focused on measuring Bariatric surgery, Post-surgery hypoxemia, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA score (American Society of Anesthesiologists ) of II or III
  • BMI > 35 kg/m²
  • Elective laparoscopic bariatric surgery: gastric bypass or sleeve

Exclusion Criteria:

  • Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease
  • Increase of the intracranial pressure
  • History of smoking with chronic obstructive disease (VEMS/CV)
  • Active tabagism
  • Ongoing pregnancy
  • History of heart failure (NYHA III or IV) or coronary artery disease
  • Urgent surgery
  • Allergy to a drug used within the study
  • Lack of written informed consent

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEEP 10 cmH20

optimal PEEP

Arm Description

In this group, a PEEP of 10 cmH20 is applied for the duration of the intervention and a recruitment maneuver is applied each time the SpO2 (oxygen pulsated saturation) drops below 95%.

In this group, 10 cmH20 PEEP is applied immediately. Then the "optimal PEEP" is sought at three key moments. It is determined by the best value of lung compliance found in the patient. It is sought by increasing or decreasing the value of the PEEP by increments or decrements of 2 cmH20. If after 6 respiratory cycles, the value of the compliance is increased, the investigator continues to increase the value of the PEEP. On the other hand, if the value of compliance is reduced, the investigator reduces the value of PEEP. The value of the PEEP selected shall in no event exceed the set pressure range (maximum pressure plate of 30 cmH20 and maximum inspiratory peak pressure 40cmH20). A recruitment maneuver is applied each time the SpO2 drops below 95%, as in the PEEP 10cmH2O group.

Outcomes

Primary Outcome Measures

Number of hypoxemia episodes (Sp02<90%)
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period.
Number of hypoxemia episodes (Sp02<95%)
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period.

Secondary Outcome Measures

Number of recruitment manoeuvers
Recruitment manoeuver are performed if patient saturation drops below 95%.
Number of recruitment manoeuvers
Recruitment manoeuver are performed if patient saturation drops below 95%.
Number of recruitment manoeuvers
Recruitment manoeuver are performed if patient saturation drops below 95%.
Number of recruitment manoeuvers
Recruitment manoeuver are performed if patient saturation drops below 95%.
Pulmonary dynamic compliance (Cd) - preoperative
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) - moment 1
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -moment 2
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -moment 3
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Anatomic dead space - preoperative
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 1
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 2
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 3
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -if recruitment manoeuvers
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
PaO2/FiO2 ratio - preoperative
Arterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 1
Arterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 2
Arterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 3
Arterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - if recruitment manoeuvers
Arterial oxygen partial pressure to fractional inspired oxygen ratio
PaCO2-EtCO2 gradient - preoperative
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
PaCO2-EtCO2 gradient - moment 1
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
PaCO2-EtCO2 gradient - moment 2
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
PaCO2-EtCO2 gradient - moment 3
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
PaCO2-EtCO2 gradient - if recruitment manoeuvers
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Number of respiratory complications
Number of hospitalisations due to respiratory complications within 30 days after surgery.
Number of postoperative wound infections
All patients are seen at the surgical consultation on day 30 after surgery. The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation).
Pre-operative physiologic measures: cardiac frequency (FC)
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: Arterial tension (TA)
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: pH
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).
Operative physiologic measures - moment 1: FC
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: PAM (Average arterial pressure)
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: pH
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: PaCO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: CO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: FC
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: PAM
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: pH
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: PaCO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: CO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: FC
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: PAM
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: pH
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: CO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: PaCO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: FC
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: PAM
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: SpO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: pH
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: PaO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: CO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: PaO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: PaO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: PaO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: SpO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: SpO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: SpO2
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)

Full Information

First Posted
October 12, 2015
Last Updated
January 18, 2018
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02579798
Brief Title
Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?
Official Title
Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used. The functional residual capacity (FRC) of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis. Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important. There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined. The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery. The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient (arterial and end tidal gradient) between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy). The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.
Detailed Description
General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used. These atelectasis are formed on one hand by the reduction of the functional residual capacity (FRC) following a compression mechanism (loss of the inspiratory muscle tone, which is accompanied by a chest wall configuration change and a diaphragm cephalic movement) and on the other hand by a denitrogenation absorption process (ventilation at high Fi02 (oxygen inspired fraction) causing complete absorption of O2 with lack of support for the alveolus, which then collapses). The FRC of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis. Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important. Several strategies have been studied in order to improve respiratory mechanics and reduce impaired gas exchange during laparoscopic surgery in obese patients. The position called "chair", mechanical ventilation with PEEP, recruitment maneuvers followed by the PEEP, and spontaneous ventilation with CPAP before extubation, are all strategies that have proven effective to decrease development these atelectasis. Currently, the scientific community agrees on the fact that PEEP improves intraoperative respiratory function (improved compliance, oxygenation) especially in conjunction with recruitment maneuvers. But there is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined. The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery. The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio, the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy). The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery
Keywords
Bariatric surgery, Post-surgery hypoxemia, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP 10 cmH20
Arm Type
Experimental
Arm Description
In this group, a PEEP of 10 cmH20 is applied for the duration of the intervention and a recruitment maneuver is applied each time the SpO2 (oxygen pulsated saturation) drops below 95%.
Arm Title
optimal PEEP
Arm Type
Active Comparator
Arm Description
In this group, 10 cmH20 PEEP is applied immediately. Then the "optimal PEEP" is sought at three key moments. It is determined by the best value of lung compliance found in the patient. It is sought by increasing or decreasing the value of the PEEP by increments or decrements of 2 cmH20. If after 6 respiratory cycles, the value of the compliance is increased, the investigator continues to increase the value of the PEEP. On the other hand, if the value of compliance is reduced, the investigator reduces the value of PEEP. The value of the PEEP selected shall in no event exceed the set pressure range (maximum pressure plate of 30 cmH20 and maximum inspiratory peak pressure 40cmH20). A recruitment maneuver is applied each time the SpO2 drops below 95%, as in the PEEP 10cmH2O group.
Intervention Type
Device
Intervention Name(s)
PEEP (positive end-expiratory pressure)
Primary Outcome Measure Information:
Title
Number of hypoxemia episodes (Sp02<90%)
Description
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period.
Time Frame
continuously during 48h after surgery
Title
Number of hypoxemia episodes (Sp02<95%)
Description
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period.
Time Frame
continuously during 48h after surgery
Secondary Outcome Measure Information:
Title
Number of recruitment manoeuvers
Description
Recruitment manoeuver are performed if patient saturation drops below 95%.
Time Frame
From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)
Title
Number of recruitment manoeuvers
Description
Recruitment manoeuver are performed if patient saturation drops below 95%.
Time Frame
From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)
Title
Number of recruitment manoeuvers
Description
Recruitment manoeuver are performed if patient saturation drops below 95%.
Time Frame
From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)
Title
Number of recruitment manoeuvers
Description
Recruitment manoeuver are performed if patient saturation drops below 95%.
Time Frame
From moment 3 till the end of the surgery (patient leaving the theater)
Title
Pulmonary dynamic compliance (Cd) - preoperative
Description
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Time Frame
Just before surgery, at ambient air contact
Title
Pulmonary dynamic compliance (Cd) - moment 1
Description
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Time Frame
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Title
Pulmonary dynamic compliance (Cd) -moment 2
Description
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Pulmonary dynamic compliance (Cd) -moment 3
Description
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers
Description
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Time Frame
Five minutes after any recruitment manoeuver
Title
Anatomic dead space - preoperative
Description
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Time Frame
Just before surgery, at ambient air contact
Title
Anatomic dead space -moment 1
Description
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Time Frame
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Title
Anatomic dead space -moment 2
Description
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Anatomic dead space -moment 3
Description
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Anatomic dead space -if recruitment manoeuvers
Description
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Time Frame
Five minutes after any recruitment manoeuver
Title
PaO2/FiO2 ratio - preoperative
Description
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Time Frame
Just before surgery, at ambient air contact
Title
PaO2/FiO2 ratio - moment 1
Description
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Time Frame
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Title
PaO2/FiO2 ratio - moment 2
Description
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
PaO2/FiO2 ratio - moment 3
Description
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
PaO2/FiO2 ratio - if recruitment manoeuvers
Description
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Time Frame
Five minutes after any recruitment manoeuver
Title
PaCO2-EtCO2 gradient - preoperative
Description
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Time Frame
Just before surgery, at ambient air contact
Title
PaCO2-EtCO2 gradient - moment 1
Description
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Time Frame
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Title
PaCO2-EtCO2 gradient - moment 2
Description
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
PaCO2-EtCO2 gradient - moment 3
Description
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
PaCO2-EtCO2 gradient - if recruitment manoeuvers
Description
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Time Frame
Five minutes after any recruitment manoeuver
Title
Number of respiratory complications
Description
Number of hospitalisations due to respiratory complications within 30 days after surgery.
Time Frame
30 days after surgery
Title
Number of postoperative wound infections
Description
All patients are seen at the surgical consultation on day 30 after surgery. The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation).
Time Frame
30 days after surgery
Title
Pre-operative physiologic measures: cardiac frequency (FC)
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Just before surgery, at ambient air contact
Title
Pre-operative physiologic measures: Arterial tension (TA)
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Just before surgery, at ambient air contact
Title
Pre-operative physiologic measures: pH
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Just before surgery, at ambient air contact
Title
Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).
Time Frame
Just before surgery, at ambient air contact
Title
Operative physiologic measures - moment 1: FC
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 1: PAM (Average arterial pressure)
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 1: pH
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 1: PaCO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 1: CO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 2: FC
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 2: PAM
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 2: pH
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 2: PaCO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 2: CO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 3: FC
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Operative physiologic measures - moment 3: PAM
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Operative physiologic measures - moment 3: pH
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Operative physiologic measures - moment 3: CO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Operative physiologic measures - moment 3: PaCO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Operative physiologic measures - if recruitment manoeuvers occurs: FC
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: PAM
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: SpO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: pH
Description
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: PaO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Five minutes after any recruitment manoeuver
Title
Operative physiologic measures - if recruitment manoeuvers occurs: CO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Five minutes after any recruitment manoeuver
Title
Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Just before surgery, at ambient air contact
Title
Operative physiologic measures - moment 1: PaO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 2: PaO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 3: PaO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat
Title
Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
Just before surgery, at ambient air contact
Title
Operative physiologic measures - moment 1: SpO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after induction/intubation, patient laying flat, without pneumoperitoneum
Title
Operative physiologic measures - moment 2: SpO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Title
Operative physiologic measures - moment 3: SpO2
Description
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Time Frame
just after pneumoperitoneum exsufflation - patient lying flat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA score (American Society of Anesthesiologists ) of II or III BMI > 35 kg/m² Elective laparoscopic bariatric surgery: gastric bypass or sleeve Exclusion Criteria: Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease Increase of the intracranial pressure History of smoking with chronic obstructive disease (VEMS/CV) Active tabagism Ongoing pregnancy History of heart failure (NYHA III or IV) or coronary artery disease Urgent surgery Allergy to a drug used within the study Lack of written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Van der Linden, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Van Hecke Delphine, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

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Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

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